Senior Safety Specialist

🔥 0 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟠 Senior

✨ Safety Specialist

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and potentially oversee day-to-day Pharmacovigilance activities in a highly regulated environment • Collect, monitor, assess, evaluate, research, and track safety information • Collaborate with project team members, client contacts, investigators, adverse-event reporters, and third-party vendors • Work independently on daily PV activities and potentially participate in on-call duties to ensure 24-hour case-intake coverage • Operate in a lead capacity and assist with developing program and departmental procedural documents • Prepare for and attend audits • Mentor less experienced staff • Review regulatory/pharmacovigilance publications and information sources • Maintain medical understanding of applicable therapeutic areas and disease states • Review cases and peer reports for quality, consistency, and accuracy • Coordinate routine project implementation, including Clinical Trials and Endpoint Assessment/Data Safety Monitoring Committees • Present at client and investigator meetings • Review metrics and budget considerations

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of comparable experience • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • Thorough understanding of pathophysiology and disease processes • Strong knowledge of relevant therapeutic areas for adverse-event processing • Excellent critical thinking and problem-solving skills, including appropriate evaluation and escalation • Proficiency in complex clinical study administration, budget activities, and forecasting • Excellent oral and written communication skills, including paraphrasing • Good command of English and ability to translate information into the local language where required • Computer literacy and ability to work within multiple databases • Proficiency in Microsoft Office, including Outlook, Word, and Excel • Thorough understanding of global regulatory requirements and compliance with procedural documents and regulations • Ability to manage and prioritize varied tasks and meet strict deadlines with limited supervision • Strong attention to detail • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work effectively within a team

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Opportunity to contribute to patient safety and scientific excellence